ABSTRACT
In a multicenter randomized double-blind, trial, 90 patients received either fleroxacin 400mg po once/day or ciprofloxacin 500mg po twice/day for treatment of complicated urinary tract infections (UTI). Treatment was administered orally and presumptively. Bacteriological efficacy was assessed 7 days post-treatment. In total, 78 patients were available for efficacy testing: 40 in the fleroxacin group and 38 in the ciprofloxacin group. The bacteriological cure rate was 92.5 percent and 94.7 and in the fleroxacin and ciprofloxacin groups, respectively. The most commonly isolated pathogen (E. coli) was erradicated in 94.1 percent and 95.8 percent of the cases in fleroxacin and ciprofloxacin groups, respectively. Eight patients in the fleroxacin group had some adverse events, two of them severe (insomnia and photodermatitis). In the ciprofloxacin group, 11 patients had adverse events of mild to moderate intensity, mainly affecting the digestive system. In conclusion, fleroxacin 400mg po once/day and ciprofloraxin 500mg po twice/day were both effective in the treatment of complicated urinary tract infections.
Subject(s)
Humans , Male , Female , Adolescent , Adult , Middle Aged , Ciprofloxacin/adverse effects , Ciprofloxacin/therapeutic use , Fleroxacin/adverse effects , Fleroxacin/therapeutic use , Urinary Tract Infections/drug therapy , Administration, Oral , Anti-Infective Agents/pharmacology , Randomized Controlled Trials as Topic , Escherichia coli/drug effects , Single-Blind MethodABSTRACT
The objective of this open label, non-comparative study was to evaluate the efficacy and safety of fleroxacin 400mg administered orally once daily to patients with acute osteomyelitis and/or acute septic arthritis. Nineteen patients (10 males and 9 females) were evaluable for the analysis of clinical efficacy and safety. Of these, 7 (36.8%) had osteomyelitis and 12 (63.2%) had septic arthritis. Bacteriological cures were reported in 6 of 7 patients (85.7%) with osteomyelitis and in 8 of 11 patients (72.7%) with septic arthritis. The median duration of treatment for the clinical cures in osteomyelitis and septic arthritis were 29.5 days and 46 days respectively. The eradication rate for the most common pathogens, Salmonella enteritidis and Staphylococcus aureus were 77.7% and 80.0%, respectively. The clinical response was cure in 4 of 7 patients (57.1%) evaluable for osteomyelitis, and in 9 of 12 patients (75.0%) evaluable for septic arthritis at the three-month follow-up after treatment. Adverse reactions were minimal. It is concluded that fleroxacin appears to be an effective and safe in the treatment of acute osteomyelitis and acute septic arthritis.